Actively Recruiting

Phase Not Applicable
Age: 15Years - 25Years
All Genders
ID07321353

Online Problem-Solving Intervention for Brain Tumor Survivors: A Two-site, Two-arm Pilot Randomized Controlled Trial

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-07

72

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

N

Nationwide Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an online program called Survivors Journey Plus (SJ+) designed to help teens and young adults aged 15 to 25 who have survived pediatric brain tumors, along with their caregivers. The study aims to see if SJ+ is feasible and acceptable, and whether it improves wellbeing compared to an internet resource comparison (IRC). The trial focuses on quality of life, internalizing symptoms, executive function skills, depression, and family impact in this group. Participants are randomly assigned to one of two groups: one receives access to the SJ+ program with weekly online coaching sessions, and the other gets access to an internet resource comparison website with pediatric brain tumor survivor information but no session content. The intervention offers training in problem-solving, stress management, metacognitive and communication skills tailored to address challenges faced by brain tumor survivors and their families. Outcomes are assessed at the start, about three months after baseline when treatment ends, and again six months after baseline. During the study, participants and caregivers complete evaluations including quality of life surveys, measures of executive function, anxiety, depression, and family impact at specified time points. Researchers track changes from baseline to six months post-baseline to assess the program's effects. The total study duration for each participant is approximately six months, with monitoring of participant wellbeing and program acceptability throughout this period.

CONDITIONS

Brief Title

Survivors Journey+

Who Can Participate

Age: 15Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A diagnosis of a pediatric intracranial tumor
  • Tumor-directed treatment completed more than 12 months ago (including surgery, radiation, or chemotherapy)
  • Lives with parent or guardian(s)
  • English is the primary spoken language in the home
Not Eligible

You will not qualify if you...

  • History of tuberous sclerosis or neurofibromatosis
  • Treatment less than 12 months ago or treatment did not include surgery, radiation, or chemotherapy
  • History of psychiatric hospitalization
  • Resides outside of the family home
  • History of autism, reactive attachment disorder, psychosis, or other psychiatric diagnoses with significant risk of harm to self or others as reported by caregiver
  • English is not the primary language spoken in the home

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - Approximately 3 months

Participants engage in a family-centered, online behavioral intervention focusing on stress management, problem-solving, metacognitive strategies, self-regulation, and communication skills tailored for pediatric brain tumor survivors and their caregivers.

1 baseline visit and 1 follow-up visit at treatment completion

Follow-up

Duration - Up to 3 months after treatment completion (6 months post-baseline)

Participants are monitored to assess lasting effects on quality of life, executive functioning, and caregiver well-being after completing the intervention.

1 follow-up visit at 6 months post-baseline

Trial Site Locations

Total: 2 locations

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

2

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

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Research Team

S

Shari L Wade, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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